BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ORION ALL SILICONE ELASTOMER COATED CATHETER

    K Number: K944376 · Decision Nov 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    126
    Applicant Total
    21
    Review Days
    84

    Basic Information

    Device Name
    ORION ALL SILICONE ELASTOMER COATED CATHETER
    K Number
    K944376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    REGULATORY & MARKETING SERVICES, INC.
    Date Received
    September 7, 1994
    Decision Date
    November 30, 1994
    Product Code
    EZL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EZL Catheter, Retention Type, Balloon

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